FDA.reportPublic FDA data

Coronary Bypass Marker

Primary DI
B776106961
Brand
Coronary Bypass Marker
Company
FIRST CALL, INC.
Model
Rev1
Catalog number
10-696
Device description
Suturing Washer
Published
2019-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MABMarker, Cardiopulmonary Bypass (Vein Marker)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MABMarker, Cardiopulmonary Bypass (Vein Marker)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052642000SUTURING WASHERFirst Call, Inc.2006-01-17MAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B776106961PrimaryHIBCC0
B7761069619Unit of UseHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015526185
Device count
3
Serial number
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026704523054PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523061PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523078PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523085PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523058PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523065PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523072PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523089PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
00846159001037SCANLAN® A/C Locator® graft markerSCANLAN INTERNATIONAL INCMAB2015-08-28
10846159001034SCANLAN® A/C Locator® graft markerSCANLAN INTERNATIONAL INCMAB2015-08-28
10846159001041Scanlan® RADIOMARK® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27
00846159025644Scanlan® RADIOMARK® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27
00846159025651Scanlan® A/C LOCATOR® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27